The British Journal of Psychiatry (2021)

Page 1 of 3. doi: 10.1192/bjp.2021.98

Editorial

Recommendations for monitoring and

reporting harm in mindfulness for
psychosis research
Lyn Ellett and Paul Chadwick

Summary
There is increasing interest in potential harmful effects of mind-
fulness-based interventions. In relation to psychosis, inconsist-
ency and shortcomings in how harm is monitored and reported
are holding back our understanding. We offer eight recommen-
dations to help build a firmer evidence base on potential harm in
mindfulness for psychosis.
Keywords
Mindfulness; psychosis; harm; schizophrenia; adverse events.
Copyright and usage
© The Author(s), 2021. Published by Cambridge University Press
on behalf of the Royal College of Psychiatrists.

A third approach to operationalising harm has been to consider

Lyn Ellett is a reader in clinical psychology at Royal Holloway, University of London, UK.
indirect or proxy indices of harm, such as study drop-out rate – the
Paul Chadwick (pictured) is Professor of Clinical Psychology and Director of the Bath
Centre for Mindfulness and Compassion, University of Bath, UK.
argument being that drop-out rates would be higher in psychothera-
pies experienced as unsafe by patients.

Is mindfulness for psychosis harmful?

One of the most significant recent developments in the field of psy-
chotherapy has been the emergence of mindfulness-based interven-
tions (MBIs). In relation to psychosis, MBIs were slow to develop, in
large part because of concern that people with psychosis are particu-
larly vulnerable to harmful effects arising from mindfulness
practice.1
Operationalising harm in psychotherapy research
Harm in psychotherapy research has traditionally been defined as
the occurrence, following an intervention, of a deterioration in
symptoms or functioning that is sustained, is likely to have been
caused by the intervention and is more severe than it would have
been had the individual not received the intervention.2 This defin-
ition highlights two immediate complexities in defining harm in
psychotherapy. First, a proportion of people with mental health
conditions will experience a deterioration in symptoms with or
without an intervention, so it is important to establish a baseline
rate of deterioration. Randomised controlled trials (RCTs) are
particularly useful in this regard, as the inclusion of a control arm
provides a valid point of comparison from within the same clinical
setting and time frame. Second, a deterioration means more than
simply a change in score – to determine the clinical significance
of a change in symptoms or functioning it is helpful to know the
minimal clinically important difference (MCID) for any given
outcome measure.
A second approach to operationalising harm that is commonly
applied in RCTs is to report the occurrence of both serious adverse
events (SAEs), defined by the World Health Organization as life-
threatening or fatal occurrences, and adverse events (AEs),
defined as untoward events experienced by study participants.
SAEs and AEs may or may not be caused by the intervention. In
a review of the available research on harm in mindfulness-based
psychotherapies across a range of conditions (but not psychosis),
Baer et al report that AEs or SAEs occur in 0–10.6% of research
participants, and are no more common in mindfulness-based
psychotherapies than in control arms of trials.2
The literature on mindfulness-based therapies for psychosis is
growing fast. An evidence base comprising more than 20 RCTs
(see Jensen et al for the most recent meta-analysis3), alongside
numerous uncontrolled studies, evidences a range of clinical bene-
fits of mindfulness for psychosis, including reduced negative symp-
toms and levels of depression, and enhanced psychological quality
of life.3 Although these randomised studies do not suggest that
mindfulness for psychosis is harmful, a closer look at how harm is
operationalised, monitored and reported in mindfulness for psych-
osis research reveals some critical shortcomings that make it impos-
sible to provide a data-driven answer to the question ‘Is mindfulness
for psychosis harmful?’ We offer below eight recommendations
(summarised in the Appendix) on how harm should be operationa-
lised, monitored and reported, to strengthen the evidence base on
potential harm in mindfulness for psychosis research.
Recommendations for reporting of harm
Study design
First, although uncontrolled research studies were pivotal to the
development of mindfulness for psychosis, priority should be
given to findings from RCTs when drawing generalisable conclu-
sions about harm. The discipline in RCTs of applying a common
set of study inclusion and exclusion criteria within a standardised
recruitment protocol, combined with the inclusion of a control
arm and random treatment allocation, provides a valid point of
comparison from which to understand observed levels of harm in
those receiving mindfulness for psychosis. Although uncontrolled
studies will always be useful in flagging important potential issues
of risk and harm, and in ongoing therapy development, they do
not provide a solid basis for drawing firm conclusions about harm
in mindfulness for psychosis.
Serious adverse events
Second, there are inconsistencies in reporting of SAEs. All future
studies should state explicitly the number of SAEs by study arm;

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 Ellett & Chadwick
if there were none, then this should be stated explicitly. This is
already a recommendation in reporting of trials, but it is not
always applied in the MBI for psychosis literature. Also, there is
some confusion about what constitutes an SAE in mindfulness for
psychosis research. For example, in one study a participant death
was not reported as an SAE because it was attributed to natural
causes. Crucially, an SAE is defined by the untoward event itself
and not by degree of imputed causal connection with study partici-
pation. Although it is informative to include indications of likely
degree of connection between a life-threatening or fatal occurrence
and study participation, it always remains an SAE and should be
reported as such.
Hospital admissions
Third, there is lack of clarity around reporting of hospital admis-
sion. As with other SAEs, it is sometimes simply not reported on
– does this mean that it was robustly monitored and did not
occur, or that it was not monitored? Harm in psychotherapy is
such an important issue that clarity is essential. Data should minim-
ally include the number of participants in each arm who were
admitted to hospital – if there were none in a study arm, then this
should be stated explicitly. If admissions were not monitored,
then this should be stated explicitly as a study limitation. Where
applicable and possible, data on hospital admissions might be sup-
plemented by data on usage of crisis or home treatment teams.
Further inconsistency can arise in trials of MBIs for psychosis
that use the hospital admission or readmission rate as an outcome
measure. Authors typically report admission rates as clinical out-
comes but not also as adverse events. This substantially distorts
reported rates of adverse events in mindfulness research. Selecting
an adverse event as a study outcome does not obviate the need
also to report it as an adverse event. Hospital admissions should
always be reported as adverse events, as is done in non-psychother-
apy research.
Adverse events
Fourth, although real-world practical constraints mean that it is not
possible to monitor all potential adverse events, what is practicable
is for researchers to follow Jacobsen et al4 in stating clearly in their
trial protocol those adverse events that were deemed particularly
relevant to the trial, specifying how these were monitored (e.g.
review of case notes) and giving detailed descriptions of any such
untoward events that did occur.
Side-effects
Fifth, researchers are encouraged to consider using a standardised
patient-reported side-effects questionnaire in trials of MBIs, as is
done in trials of medication. None of the trials included in the
most recent meta-analysis3 of MBIs for psychosis did so. Side-
effects are distinct from adverse events and will occur in all psy-
chotherapies. Recording subjective side-effects will broaden under-
standing of potential harm in MBIs for psychosis.
Symptom deterioration
Sixth, although studies increasingly seek to contextualise benefits of
MBIs by reporting the number of participants who showed a clinic-
ally important improvement on measures of psychological func-
tioning, it is rare for studies to report how many participants
experienced a clinically important deterioration. None of the rando-
mised trials of MBIs for psychosis included in the most recent
meta-analysis3 reported data across all study arms on clinically
important deterioration on the primary measure of psychological
functioning – and we have found only one RCT published since
2
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then that included data on clinically important deterioration on
the primary outcome measure across all study arms.5 Whenever
possible, clinically important symptom deterioration by study arm
should be reported in all future studies.
Drop out
Seventh, drop out occurs for many reasons but it can be a useful indir-
ect index of harm. CONSORT diagrams show study drop out – the
number of participants who did not provide post-intervention or
follow-up data. However, a participant who ceased attending
therapy yet still provided post-intervention assessment data would
not be recorded as a study ‘drop out’. It would be useful for future
studies to report not only study drop-out rates (including, where
known, the reason), but also therapy non-completion rates as deter-
mined against a preset number of sessions (e.g. attending at least 50%
of sessions).
Public and patient involvement
Finally, it will be important in future studies to ensure meaningful
public and patient involvement (PPI) in research assessing harm.
Studies are encouraged to state explicitly if and how PPI input con-
tributed to specific decision-making on how harm was operationa-
lised and monitored.
Conclusions
There is a pressing need to improve monitoring and reporting of
harm in mindfulness for psychosis research – indeed, in the wider
literature on MBIs – in order to develop a fuller understanding of
both beneficial and harmful effects.
Lyn Ellett, Department of Psychology, Royal Holloway, University of London, UK;
Paul Chadwick , Department of Psychology, University of Bath, UK
Correspondence: Paul Chadwick. Email: pdjc20@bath.ac.uk
First received 13 Jan 2021, final revision 8 Jun 2021, accepted 14 Jun 2021
Author contributions
Both authors contributed equally to all aspects of the manuscript. Both authors have approved
the final version to be published and agree to be accountable for the accuracy and integrity of
the work.
Funding
This research received no specific grant from any funding agency, commercial or not-for-profit
sectors.
Declaration of interest
None.
Appendix
Criteria and recommendations
(a) Study design:
(i) data from randomised controlled trials should be priori-
tised when drawing generalisable conclusions about
harm in mindfulness for psychosis research.
(b) Serious adverse events:
(i) all life-threatening and fatal occurrences should be
reported as serious adverse events (SAEs), regardless
of degree of causal connection with study participation
 Reporting harm in mindfulness for psychosis research

(ii) if there were no SAEs, this should be clearly stated (g) Drop out:
(iii) if SAEs were not monitored, this should be listed as a (i) report study drop out, and reason for drop out (includ-
study limitation. ing direct or indirect link to harm), by treatment arm
(c) Hospital admissions: (ii) report separately drop out and non-completion of
(i) hospital admissions should always be reported as therapy.
adverse events, even when admission is a study outcome (h) Public and patient involvement (PPI):
(ii) if there were none, this should be clearly stated (i) ensure meaningful PPI in decision-making about how
(iii) should be supplemented with data on usage of crisis harm is operationalised and monitored.
services if possible
(iv) if admissions were not monitored, this should be listed
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